FDA Device recall Z-1281-2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering can…
- FDA Device
- Class II
- ongoing
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering can… by Raysearch Laboratories Ab, citing patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1281-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-03 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
Reason
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
Identifiers
| code_info | S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1281-2021%22
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